MISOPROSTOL PFIZER TABLET

Land: Südafrika

Sprache: Englisch

Quelle: South African Health Products Regulatory Authority (SAHPRA)

Verfügbar ab:

Pfizer Laboratories (Pty) Ltd

Dosierung:

See ingredients

Darreichungsform:

TABLET

Zusammensetzung:

EACH TABLET CONTAINS MISOPROSTOL 200 ug

Berechtigungsstatus:

Registered

Berechtigungsdatum:

1989-04-10

Gebrauchsinformation

Pfizer Laboratories (Pty) Ltd.
Page 1 of 5
Misoprostol Pfizer
Final approved PIL – 16 February 2023
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
S4
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM:
MISOPROSTOL PFIZER
®
(tablets)
READ THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE MISOPROSTOL
PFIZER.
▪
Keep this leaflet. You may need to read it again.
▪
If you have further questions, please ask your doctor or pharmacist.
▪
MISOPROSTOL PFIZER has been prescribed for you personally and you
should not
share your medicine with other people. It may harm them, even if their
symptoms are
the same as yours.
1. WHAT MISOPROSTOL PFIZER CONTAINS
The active ingredient of MISOPROSTOL PFIZER is misoprostol.
The inactive ingredients include; microcrystalline cellulose, sodium
starch glycolate and
hydrogenated castor oil.
2. WHAT IS MISOPROSTOL PFIZER USED FOR:
MISOPROSTOL PFIZER is used for co-administration with non-steroidal
anti-inflammatory
drugs (NSAIDs) for the prevention of gastric and duodenal ulcers,
haemorrhagic lesions
and erosions induced by NSAIDs.
Pfizer Laboratories (Pty) Ltd.
Page 2 of 5
Misoprostol Pfizer
Final approved PIL – 16 February 2023
3. BEFORE YOU TAKE MISOPROSTOL PFIZER:
If you are taking medicines on a regular basis, concomitant use of the
medicine may cause
undesirable interactions. Please consult your doctor, pharmacist or
other health care professional
for advice.
DO NOT TAKE MISOPROSTOL PFIZER:
If you are pregnant or breast feeding.
If you are allergic to misoprostol or other prostaglandins or any of
the other ingredients of
MISOPROSTOL PFIZER.
TAKE SPECIAL CARE WITH MISOPROSTOL PFIZER:
Some people will need special care from their doctors when they are
taking
MISOPROSTOL PFIZER. If the answer to any of the following questions is
“yes”, you
should talk to your doctor or pharmacist before taking MISOPROSTOL
PFIZER as it may
not be suitable for you:
▪
Have you ever had a reaction to misoprostol or any of its ingredients?
▪
Are you pregnant, trying to become pregnant, or breas

Fachinformation

Pfizer Laboratories (Pty) Ltd.
Page 1 of 8
Misoprostol Pfizer
Final approved PI – 16 February 2023
SCHEDULING STATUS: S4
PROPRIETARY NAME AND DOSAGE FORM:
MISOPROSTOL PFIZER
®
Tablets
COMPOSITION:
Each tablet contains 200 mcg misoprostol.
The inactive ingredients include; microcrystalline cellulose, sodium
starch glycolate and
hydrogenated castor oil.
PHARMACOLOGICAL CLASSIFICATION:
A 11.10 Medicines acting on the gastro-intestinal tract - Special
combinations and/or
substances.
PHARMACOLOGICAL ACTION:
Misoprostol is a synthetic prostaglandin E
1
analogue which has gastric antisecretory and
mucosal protective properties. The antisecretory activity is mediated
by direct action on
specific prostaglandin receptors on the surface of gastric parietal
cells. The mucosal protective
effect against various damaging agents has been demonstrated in humans
with doses that
inhibit, and doses which minimally affect acid secretion.
ANTISECRETORY ACTIVITY:
_Effect on acid secretion_: In healthy human subjects, misoprostol
inhibits daytime and nocturnal
basal gastric acid secretion and acid secretion stimulated by
histamine, pentagastrin, food,
tetragastrin, betazole and coffee.
_Effect on pepsin secretion and gastric fluid volume_: Misoprostol
decreases pepsin and gastric
volume under basal conditions.
Pfizer Laboratories (Pty) Ltd.
Page 2 of 8
Misoprostol Pfizer
Final approved PI – 16 February 2023
_Effect on serum gastrin_: Misoprostol has no persistent effects on
fasting levels of, or on
postprandial increase in, serum gastrin.
MUCOSAL PROTECTIVE ACTIVITY:
Misoprostol has properties in animals and humans that strengthen the
integrity of the
gastroduodenal mucosal barrier against damaging agents. These include
stimulation of
duodenal bicarbonate secretion and gastric mucus production. In
addition, misoprostol
maintains mucosal haemodynamics.
OTHER PHARMACOLOGICAL EFFECTS:
Misoprostol has been shown to produce uterine contractions which may
endanger pregnancy
(see Contraindications).
Misoprostol does not produce clinically